About Dutasteride API
Therapeutic CategoryUrology
CAS Number
164656-23-9
API Technology
Synthetic
Dose Form
Oral Solid/Capsules
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF
Mechanism of Action
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Testosterone is converted to DHT by the enzyme 5 alpha-reductase, which exists as 2 isoforms, type 1 and type 2. The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver.
Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes, with which it forms a stable enzyme complex. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride does not bind to the human androgen receptor.
Indication
AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- Improve symptoms,
- Reduce the risk of acute urinary retention, and
- Reduce the risk of the need for BPH-related surgery.
AVODART in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
Limitations of Use: AVODART is not approved for the prevention of prostate cancer.
Related APIs
Dutasterida
Urology
Mirabegron (Alfa)
Urology
Testosterona
Urology
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Related Resources
FAQs
Store at room temperature between 20°C and 25°C.
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Dutasteride is used alone or in combination with tamsulosin (Flomax®) to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older.
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Women and children should not use this medicine. Pregnant women or women who may become pregnant should not handle or touch the capsules. Dutasteride can be absorbed through the skin and can cause birth defects in male fetuses.
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Dutasteride belongs to class 4 of BCS classification
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Dutasteride is available in capsule dosage form with 0.5 Mg strength
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We offer polymorphic form 2
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